Impact of multifaceted health education on influenza vaccination health literacy in primary school students: a cluster randomized controlled trial

Abstract

Background: Influenza remains a significant public health concern globally. We assessed the impact of multifaceted health education on influenza vaccination rates and health literacy among primary school students in China. Methods: This cluster randomized controlled trial enrolled fourth- and fifth-grade students from 20 primary schools in Dongguan, China. Schools were randomly allocated (1:1) by a computer program to either the intervention group, receiving multifaceted health education, or the control group, receiving standard health education. Data were collected at baseline and post-intervention. The primary outcome was influenza vaccination rate. Secondary outcomes included health literacy, influenza incidence, influenza-like illness incidence, and influenza vaccine protection rate. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed. Results: A total of 3463 students (1544 [44.6%] females; mean [SD] age, 9.9 [0.7] years) were enrolled. The ITT analysis included 3463 participants (control group [n = 1811]; intervention group [n = 1652]) while the PP analysis included 3275 participants (control group [n = 1717]; intervention group [n = 1558]). The influenza vaccination rate was significantly higher in the intervention group than the control group (ITT: 173 [10.9%] vs 130 [7.4%], adjusted risk ratios 1.54 [95% CI, 1.23–1.93], P < 0.001; PP: 165 [10.6%] vs 116 [6.8%], adjusted risk ratios 1.61 [95% CI, 1.27–2.03], P < 0.001). The knowledge component of children’s health literacy scores significantly increased in the intervention group post-intervention (ITT: mean differences 0.12 [95% CI 0.04–0.20], P < 0.01; PP: mean differences 0.12 [95% CI 0.04–0.21], P < 0.01). No significant differences were observed for other secondary outcomes. Conclusions: The multifaceted health education significantly enhanced influenza vaccination uptake in primary school students. However, the increase was modest, indicating that more effective school-based influenza prevention programs are urgently needed to improve vaccine uptake in children. Trial registration: Registered at ClinicalTrials.gov on 09/08/2023 (registration number: NCT06048406).